FDA Inspection Triggers Recall by Florida Pharmacy

The Food and Drug Administration has warned doctors and pharmacists to avoid drugs made by a Florida specialty pharmacy called The Compounding Shop, due to potential safety problems uncovered by health inspectors. The St. Petersburg, Fla.-based pharmacy has agreed to recall all of its sterile drugs and is in the process of notifying customers, the FDA said in a statement. The agency said health care professionals should quarantine drugs from the company and not administer them to patients. The Compounding Shop is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors’ specifications. The FDA has been cracking down on compounding pharmacies across the country, triggering several national recalls.

The wave of inspections was the result of the nationwide fungal meningitis outbreak last year tied to contaminated drugs from a Massachusetts pharmacy. As has been widley reported, the outbreak sickened more than 700 Americans and killed more than 50 others. The FDA said a recent inspection of The Compounding Shop raised concerns about sterility problems with company drugs that could lead to bacterial contamination. “If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients,” said Janet Woodcock, director of FDA’s drug center, in a statement. Patients who received products from the pharmacy and have concerns should contact their doctor.